MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-27M

Device Problems Leak/Splash (1354); Material Perforation (2205)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/10/2017

Event Type  Injury  

Event Description

On (b)(6) 2014, a double valve replacement was performed.This 27 mm epic valve was implanted in the mitral position, and a 29 mm epic valve (serial unknown) in the tricuspid position.Since (b)(6) 2016, the patient had been symptomatic with cardiac insufficiency.On an unknown date, an echocardiogram detected that one of the cusps of 27 mm epic valve (mitral) was not moving normally.On (b)(6) 2017, a re-do mitral valve replacement was performed due to mitral regurgitation and the 27 mm valve was explanted.Upon explant, there was a large perforation found on one cusp which was consistent with the abnormal movement noted by echocardiogram as it was located towards the posterior leaflet.Subsequently, a 25 mm carpentier-edwards perimount magna ease mitral heart valve was implanted.The patient has been in stable condition postoperatively.The 29 mm epic valve remains implanted in the tricuspid position with no issues.According to the surgeon, the patient has had a medical history of active infective endocarditis which may have led to this incident.

Manufacturer Narrative

The results of the investigation concluded that cusps 1 and 2 contained tears and degenerative changes with loss of collagen fibers, while cusp 3 contained outflow pannus.Special stains were negative for organisms and no acute inflammation or significant calcifications were present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the causes of the tears, collagen loss or pannus were due to an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause for the reported event remains unknown.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6771347
• MDR Text Key: 81953551
• Report Number: 3001883144-2017-00052
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3747234
• Other Device ID Number: 05414734027526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 47